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Clinical Trials in Spain / NCT02915120
Recruiting Not applicable

Ultrasound-Guided Pulsed Radiofrequency In The Treatment Of Patients With Osteoarthritis Knee (USPRFGENOAK)

NCT02915120 · tracked via the Priya Life Science Spain tracker
Phase
Not applicable
Started
2017-03-27
Last updated
2024-11-12

Condition(s) studied

Osteoarthritis, Knee

Investigational drug(s) / intervention(s)

Real Pulsed RadiofrequencySham Pulsed Radiofrequency

Real Pulsed Radiofrequency: Pulsed Radiofrequency uses radiofrequency current in short (20 ms), high-voltage bursts; the "silent" phase (480 ms) allows time for heat elimination, generally keeping the target tissue below 42° C. The Radiofrequency (RF) electrode will be inserted through the canula, and RF lesions will be generated by applying pulsed RF treatment to the inferomedial (IM), superomedial (SM), and superolateral (SL) GN branches for 8 minutes at 42°C.

Sham Pulsed Radiofrequency: Control patients will undergo the same procedure. The sensorial and motor stimulations will be applied too. The RF electrode will be then inserted through the cannula, and RF lesions will be simulated without applying pulsed RF treatment to the IM, SM and SL, GN branches for 8 minutes each GN branch and the temperature of the electrode tip was not raised.

Study summary

The purpose of this study is to determine if patients with chronic painful knee osteoarthritis experience meaningful and long-term improvement in pain, function, and analgesic use after ultrasound-guided pulsed radiofrequency of the genicular nerves following a double diagnostic genicular nerve blocks.

Eligibility

Sex
ALL
Min age
40 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Chronic knee pain with pain intensity of at least 4 out 10 on the VAS on most or all days for more than 3 months * Patients of either sex with primary osteoarthritis of one or both knees fulfilling diagnostic criteria for osteoarthritis knee laid down by American College of Rheumatology. * Patients also had to have a Kellgren-Lawrence (radiologic criterion) score of at least 2 * Pain resistant to conventional therapy including NSAIDs, opioids, muscle relaxants, oral steroids, physical therapy, and intra-articular injection therapy. Exclusion Criteria: * The patients with secondary osteoarthritis of knees * Associated systemic arthropathies, e.g. rheumatoid arthritis and gout * Previous radiofrequency ablation treatment for similar symptoms. * Intra-articular knee corticosteroid or hyaluronic acid injection in the past 3 months. * Active systemic or local infections at the site of proposed needle and electrode placement. * Coagulopathy or other bleeding disorder * Cognitive deficit. * Unstable medical or psychiatric illness. * Previous knee joint replacement surgery * Patients missing two or more appointments consecutively were excluded from the study

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Son Llatzer University Hospital Palma Balear Islands Recruiting

More Hospital Son Llatzer trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02915120 on ClinicalTrials.gov ↗ ← All trials in Spain